Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
NCT07108166 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290
Last updated 2026-05-07
Summary
The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.
Conditions
- COPD
- Smoking
- Tobacco Use
Interventions
- OTHER
-
Cigarette
COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
- OTHER
-
THS
COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.
Sponsors & Collaborators
-
Philip Morris Products S.A.
lead INDUSTRY
Principal Investigators
-
Xavier Jaumont, MD · Philip Morris Products S.A.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-02
- Primary Completion
- 2026-08-31
- Completion
- 2026-11-30
Countries
- United States
- Bulgaria
- Czechia
- Germany
- Japan
- Poland
- Romania
- Slovakia
- United Kingdom
Study Locations
More Related Trials
-
Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
NCT00535366 ·Status: COMPLETED ·Phase: PHASE2
-
Modeling Bronchial Epithelium Modifications Associated With COPD Using iPS
NCT03181204 ·Status: COMPLETED
-
Comparative Effectiveness of COPD Treatments
NCT03376295 ·Status: COMPLETED
-
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758459 ·Status: COMPLETED ·Phase: PHASE2
-
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
NCT01033487 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
NCT03235726 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)
NCT04441788 ·Status: TERMINATED ·Phase: PHASE2
-
TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol
NCT04088942 ·Status: WITHDRAWN ·Phase: PHASE4
-
Effects of Tiotropium on Walking Capacity in Patients With COPD
NCT01307189 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
NCT00219622 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
NCT00242333 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of COPD Standardized Management on COPD Exacerbation
NCT04664491 ·Status: RECRUITING ·Phase: NA
-
Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
NCT00791518 ·Status: COMPLETED
-
Enhancement of in-Vitro GC Function in Patients With COPD
NCT00241631 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD
NCT00530842 ·Status: COMPLETED ·Phase: PHASE4
-
A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)
NCT00239421 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT02130635 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01708057 ·Status: TERMINATED ·Phase: PHASE2
-
A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
NCT01313637 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic Study in Elderly Patients With Chronic Obstructive Bronchitis (COPD)
NCT02172326 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
NCT01387230 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
NCT02642614 ·Status: COMPLETED ·Phase: PHASE1
-
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
NCT00939211 ·Status: COMPLETED ·Phase: PHASE2
-
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
NCT02291016 ·Status: COMPLETED ·Phase: NA
-
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00703391 ·Status: COMPLETED ·Phase: PHASE2